Idodentine Disc, Idodentine Block
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150432 FDA 510(k)
- FDA Product Code
- EBG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3770 FDA 510(k)
- Regulation Number
- 872.3770 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Idodentine Disc and Idodentine Block are hot-cured polymethyl methacrylate (PMMA) polymer blanks designed for subtractive milling in dental laboratories. These materials serve as intermediate substrates for fabricating custom dental prostheses, including temporary crowns, bridges, implant-supported restorations, denture bases, and bite splints. Their composition and form enable precise milling via CAD/CAM systems to achieve final prosthetic shapes. The device falls under the classification of dental milling blanks, intended for subtractive processing in restorative dentistry.
These polymer blanks are supplied as either discs or blocks and are intended for single-use in dental laboratories or clinics. They are compatible with standard CAD/CAM milling systems and require no additional sterilisation, as they are processed directly into end products. The device holds FDA 510(k) clearance (K150432) under the Dental (DE) advisory committee and is also authorised under the EU Medical Device Regulation (MDR). Storage conditions and shelf life are not specified in the regulatory data, but standard dental laboratory practices should be followed to maintain material integrity.
Frequently asked questions
What types of dental prostheses can the Idodentine Disc and Block be used to create, and how does the milling process work?
The Idodentine Disc and Block are designed for subtractive milling in dental labs to fabricate custom dental prostheses like temporary crowns, bridges, implant-supported restorations, denture bases, and bite splints. The hot-cured polymethyl methacrylate (PMMA) material is milled via CAD/CAM systems to precisely shape the blanks into the final prosthetic form, enabling tailored restorations for patients.
Are the Idodentine Disc and Block meant for reuse, or are they single-use materials?
The Idodentine Disc and Block are explicitly labeled for single-use in dental laboratories or clinics. Since they are processed directly into end products without requiring sterilization, they are not intended for reuse after milling.
What regulatory pathways have the Idodentine Disc and Block followed, and which advisory committee was involved?
The Idodentine Disc and Block received FDA clearance through a 510(k) submission (K150432) under the Dental (DE) advisory committee, with a decision classified as *Substantially Equivalent*. They are also authorized under the EU Medical Device Regulation (MDR). The product code assigned is EBG, reflecting their classification as dental milling blanks.
Do these materials require sterilization before use, and how should they be stored?
No, the Idodentine Disc and Block do not require sterilization—they are processed directly into end products during milling. While specific storage conditions and shelf life aren’t detailed in the regulatory data, standard dental laboratory practices should be followed to preserve material integrity, such as keeping them in a clean, dry environment away from extreme temperatures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IDODENTINE DISC, IDODENTINE BLOCK (K150432) — FDA 510 (k) | Innolitics, IDODENTINE DISC, IDODENTINE BLOCK 510(k) K150432 - FDA.report, Manufacturing dental products. High quality parts - Unidesa Odi
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K150432 | Class II | Active |
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Manufacturer
- Manufacturer
- Union Dental S.a.
Sources (2)
- FDA 510(k) K150432 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026